Anchor deployment for implantable medical devices

ABSTRACT

A tool for deploying an anchor sleeve onto an implantable device includes handle and base members, which may be fitted together by an operator. The operator may select the handle member from a plurality thereof included in a kit; and the base member, also included in the kit, includes a rail segment with which a gripping portion of the selected handle member may be engaged, for example, via guidance from a marked portion of the base member. Once engaged, a deployment tip of the base member is located to move a mounted anchor sleeve from a tubular member of the handle member and onto a body of the device. The tubular member of some tools has a laterally offset distal end portion, on which the corresponding anchor sleeve is mounted; thus, kits including this type of handle member, may include a converter for the base member to facilitate engagement therewith.

RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 15/400,140, filed Jan. 6, 2017, now allowed, which is a divisionalapplication of U.S. application Ser. No. 14/179,766, now granted as U.S.Pat. No. 9,566,049, which claims the benefit of U.S. application Ser.No. 61/776,200, now expired. The entire content of each of these U.S.applications is incorporated herein by reference.

TECHNICAL FIELD

The present disclosure is related to implantable medical devices, andmore particularly to anchor deployment apparatus and methods.

BACKGROUND

A variety of elongate implantable medical devices, for example, drugdelivery catheters and medical electrical leads, are known in the art,for example, to couple a therapy delivery generator and/or diagnosticdevices to a target site within a body of a patient, for example, in thespinal column or in any of a number of internal organs. Those skilled inthe art are familiar with apparatus and methods for anchoring theseimplanted devices. FIG. 1A is a schematic depicting a surgical incisionsite 12 through which an exemplary elongate medical device 110 has beenimplanted. FIG. 1A illustrates a length of device 110 extendingproximally out from site 12 and an anchor sleeve 10 surrounding a bodyof device 110, for example, with a relatively tight, interference fit,to facilitate anchoring of device 110 to subcutaneous fascia 14, forexample, via sutures tied thereabout and sewn into the fascia 14. Anchorsleeve 10 may be any of a variety of types known in the art such astypes 10A, 10B and 10C shown in FIG. 1B. In order to properly positionsuch a snug fitting anchor sleeve 10 around the body of implanted device110, an anchor deployment tool may be employed. Examples of such a toolare described in a co-pending and commonly assigned U.S. patentapplication Ser. No. 12/896,147, now granted as U.S. Pat. No. 8,632,502.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular embodiments of thepresent disclosure and therefore do not limit the scope. The drawingsare not to scale (unless so stated) and are intended for use inconjunction with the explanations in the following detailed description.Embodiments will hereinafter be described in conjunction with theappended drawings wherein like numerals/letters denote like elements,and:

FIG. 1A is a schematic depicting a surgical incision site through whichan exemplary elongate medical device has been implanted;

FIG. 1B is a perspective view of a variety of types of exemplary anchorsleeves;

FIG. 1C is a perspective view of an exemplary anchor deployment toolpositioned around a proximal length of the exemplary medical device,according to some embodiments;

FIG. 2 is a perspective view of members of an exemplary kit, accordingto some embodiments;

FIG. 3A is a perspective view of an anchor sleeve positioned relative toa handle member of the exemplary deployment tool, for assembly thereon,according to some embodiments;

FIG. 3B is a perspective view of the handle member positioned forfitting together with a base member to form the exemplary deploymenttool, according to some embodiments and methods;

FIGS. 4A-B are perspective views of the exemplary deployment tool,according to some embodiments;

FIG. 5A is a perspective view of an exemplary deployment tool, accordingto some alternate embodiments;

FIG. 5B is an exploded perspective view of the exemplary tool of FIG.5A;

FIG. 5C is a perspective view of an exemplary converter for a kit,according to some embodiments;

FIG. 6A is a perspective view of an exemplary deployment tool, accordingto some additional embodiments;

FIG. 6B is an exploded perspective view of the exemplary tool of FIG.6A;

FIG. 6C is a perspective view of members of an exemplary kit, accordingto some alternate embodiments;

FIG. 6D is an exploded perspective view of portions of an exemplaryadjustable tool, according to some alternate embodiments;

FIG. 6E is a perspective view of an exemplary converter, according tosome alternate embodiments;

FIG. 7 is a perspective view, including a cut-away cross-section, of anexemplary deployment tool, according to yet further embodiments; and

FIG. 8 is a perspective view of an exemplary deployment tool, accordingto another alternate embodiment.

DETAILED DESCRIPTION

The following detailed description is exemplary in nature and is notintended to limit the scope, applicability, or configuration of thedisclosure in any way. Rather, the following description providespractical examples, and, after reading the present disclosure, thoseskilled in the art will recognize that some of the examples may havesuitable alternatives.

FIG. 1C is a perspective view of an exemplary anchor deployment tool 100positioned around a proximal length of medical device 110, according tosome embodiments. FIG. 1C illustrates tool 100 including a base member200 and a handle member 210B, which is held in sliding engagement withbase member 200, for example, by a gripping portion 213 thereof; handlemember 210B is shown including an elongate tubular member 211 on whichanchor sleeve 10B is mounted. A longitudinal axis 15 of tool 100 may bedefined by a rail segment 230 of base member 200 and/or by grippingportion 213 of handle member 210B. FIG. 1C further illustrates basemember 200 including a deployment tip 201, which is located in closeproximity to anchor sleeve 10B. According to the illustrated embodiment,when base member 200 is pushed, per arrow P, relative to handle member210B and device 110, deployment tip 201 engages a proximal end 102 ofanchor sleeve 10B to move sleeve 10B off tubular member 211, per arrowM, and onto medical device 110. With reference to FIG. 4A, which is adifferent perspective view of tool 100, it may be seen that an innersurface of tubular member 211 defines a lumen 30, which extends from anopening at a distal end 31 of member 211 to an opening at a proximal end32 of member 211, and which is sized to receive, in sliding engagement,the proximal length of implanted device 110, as shown in FIG. 1C. FIG.4A further illustrates a channel 205 of base member 200, which alsoreceives the proximal length of device 110, as shown in FIG. 1C.

FIG. 2 is a perspective view of members of the exemplary deployment tool100, which may be included in an exemplary kit 275, according to someembodiments. Kit 275 is shown including base member 200 and, separatedtherefrom, at least two types of handle member 210, wherein the twotypes, 210A and 210B, differ from one another only in that handle member210A has anchor sleeve 10A mounted thereon and handle member 210B hasanchor sleeve 10B mounted thereon. FIG. 2 illustrates tubular member 211of each handle member 210A, 210B extending distally from grippingportion 213 of the corresponding handle member 210A, 210B. FIG. 2further illustrates base member 200 including a distal segment 220, aproximal segment 240, and rail segment 230, which has recessed opposingsidewalls 3, 4, and which extends between distal segment 220 andshoulders 340 of proximal segment 240; channel 205, which is formed in afirst side 1 of base member 200, extends proximally from an opening atdeployment tip 201, through distal segment 220, and through rail segment230, and into proximal segment 240. According to the illustratedembodiment, rail segment 230 and channel 205 of base member 200 areconfigured to receive gripping portion 213 of either handle member 210A,or handle member 210B in sliding engagement, as will be described ingreater detail below. Thus, kit 275 provides an operator a choice of atleast two types of pre-mounted anchor sleeves, which choice may be amatter of functional requirements for a particular implant locationand/or personal preference, and which saves the operator the trouble ofmounting the selected anchor sleeve onto handle member 210. It should benoted that alternate kit embodiments include additional similar handlemembers on which other types of sleeves are mounted, and/or differenttypes of handle members with pre-mounted anchor sleeves, and/or otherelements, which will described below, in conjunction with FIGS. 5A-6C.

FIG. 3A is a perspective view of anchor sleeve 10B positioned relativeto handle member 210, for assembly thereon. According to some preferredembodiments, so that sleeve 10B effectively grips around device 110,after being deployed thereon, sleeve 10B is formed from an elasticmaterial, for example, medical grade silicone rubber, and has a relaxedinner diameter that is smaller than an outer diameter of device 110. Asmentioned above, the inner surface of tubular member 211 defines a lumenwhich receives a proximal length of device 110, so a diameter of theouter surface of tubular member 211 is such that sleeve 10 is stretched,or expanded, when mounted on tubular member 211. Distal end 31 oftubular member 211 may be formed with a taper, and/or a tapered lead-intip (not shown) may be temporarily coupled to distal end 31 tofacilitate the assembly of sleeve 10B onto member 211. According to somepreferred embodiments, tubular member 211 is a stainless steel hypo-tubewith a lubricious coating forming the outer surface thereof, forexample, a fluoropolymer coating (PTFE or ETFE), which can facilitatethe assembly of sleeve 10B onto member 211, as well as the movement ofsleeve 10B off of member 211 and onto device 110, by engagement ofdeployment tip 201 of tool 100, as described above, in conjunction withFIG. 1C.

According to some embodiments of the present disclosure, after sleeve10B is mounted on tubular member 211, handle member 210B is packagedalong with other handle members, such as handle member 210A, and basemember 200, to form a kit, such as exemplary kit 275 (FIG. 2), which isultimately delivered to an operator who is implanting an elongatemedical device, such as device 110. Thus, according to some methods ofthe present disclosure, the operator may select and remove from kit 275one of handle members 210A, 210B and base member 200 to form adeployment tool, after implanting the device. For example, withreference to FIG. 3B, the operator selects handle member 210B andpositions handle member 210B relative to base member 200, as shown, tofit the two members together and, thereby, form tool 100. FIG. 3B showsbase member 200 including an optional exemplary alignment mark, forexample, a marked portion 33, located in proximity to distal segment220, and shows base member 200 located with respect to handle member210B, so that optional marked portion 33 is approximately aligned withgripping portion 213 of handle member 210B. Optional marked portion 33may be formed by an arrow mark 303 and/or a strip, or length, ofcolorant that contrasts with a color of the remainder of rail segment230; arrow mark 303 may facilitate a proper orientation of channel 205toward handle member 210B. Handle member 210B may also include arrowmark 303 formed on gripping portion 213, as shown, which furtherfacilitates alignment and the proper orientation of handle member 210Bfor fitting together with base member 200.

After properly aligning and orienting handle member 210B and base member200, the operator engages marked portion 33 of base member 200 withgripping portion 213 of handle member 210B, for example, by positioninga rearward alignment portion 215 of handle member 210B around railsegment 230, and then pressing gripping portion 213 and marked portion33 of rail segment 230 together in the direction indicated by arrowmarks 303. With further reference to FIGS. 3B and 4A, when handle member210 is engaged with base member 200, as facilitated by marked portion33, a segment 35 of tubular member 211 of handle member 210B, whichextends between proximal end 102 of mounted anchor sleeve 10B andgripping portion 213, is received in a portion of channel 205 thatpasses through distal segment 220 of base member 200, such thatdeployment tip 201 of base member 200 is in close proximity to end 102of mounted sleeve 10B, as shown in FIG. 1C. According to the illustratedembodiment, gripping portion 213 includes opposing arms 203 that flexoutward and then snap into place around rail segment 230, as railsegment 230 is inserted therebetween, so that arms 203 hold handlemember 210B in sliding engagement with rail segment 230 of base member200.

With further reference to FIG. 3A, a junction between tubular member 211and gripping portion 213 is formed by a press fit of a proximal lengthof tubular member 211 within a bore hole that is formed through an innerridge 231 of gripping portion 213, wherein inner ridge 231 extendsbetween opposing arms 203 and is configured to fit in sliding engagementwithin channel 205 of base member 200, when arms 203 are fitted aroundrail segment 230. According to some embodiments, the junction betweentubular member 211 and gripping portion 213 is further formed by flaringproximal end 32 of tubular member 211, so that the flared end abuts asurface of ridge 231 that extends around an opening of the bore hole.According to some exemplary embodiments, base member 200 and handlemember 210 are each formed, for example, by injection molding, from asuitable hard plastic material, for example, polycarbonate; and astainless steel hypo-tube that forms tubular member 211 may be press fitinto inner ridge 231 following molding, or handle member 210 may beinsert molded around tubular member 211.

According to some methods, the operator may insert the proximal lengthof the implanted elongate device, for example, device 110, through lumen30 of tubular member 211 prior to fitting handle member 210B togetherwith base member 200; alternately, members 210B, 200 may be fittedtogether and then the proximal length of the implanted device insertedthrough lumen 30. In either case, once members 210B, 200 are assembledtogether and the proximal length of device 110 inserted through thelumen of tubular member 211, sleeve 10B may be deployed (e.g., moved offof tubular member 211 of handle member 210), as described above inconjunction with FIG. 1C. With reference to FIG. 1C, in conjunction withFIGS. 4A-B, the operator may push base member 200, with respect tohandle member 210, per arrow P, by placing a fingers of his hand againstan abutment surface 41 of each laterally extending tab element 214 ofhandle member 210, and placing a thumb of the hand against anotherabutment surface 44 of base member 200, which is formed at a proximalterminal end 440 thereof.

With reference to FIG. 4B, according to some embodiments, optionalmarked portion 33 of rail segment 230, for example, when formed by theaforementioned length of contrasting color, extends along a second side2 of base member 200, and has a length which is approximately equal tothat of anchor sleeve 10B, so that, according to some methods, theoperator may monitor the movement of marked portion 33 relative togripping portion 213 of handle member 210, while pushing base member200, to determine when sleeve 10B has been completely moved off tubularmember 211. For example, when the operator sees that a proximal end 332of the length of marked portion 33 has moved distal to gripping portion213, he may use this as an indication that sleeve 10B is deployed arounddevice 110. FIG. 4B further illustrates second side 2 of base member 200including holes 421 formed therethrough, wherein holes 421 are locatedalong rail segment 230 in proximity to distal segment 220. Thus, if tool100 is assembled for packaging (rather than being disassembled in kitform), with arms 203 of handle member 210 fitted around base member 200in the above-described aligned engagement (with proximal end 102 ofmounted anchor sleeve 10B located for engagement with deployment tip201, as shown in FIG. 1C), holes 421 will allow sterilization gases toflow into that portion of channel 205 where ridge 231 of handle member210 is received.

With further reference to FIGS. 1C and 4A, channel 205 extends intoproximal portion 240 of base member 200 and is terminated by a rampedportion 45, for example, to provide a smooth exit transition for theproximal length of device 110 that is received in channel 205 whilesleeve 10B is being deployed thereon. FIGS. 3B and 4A-B, furtherillustrate shoulders 340 of proximal segment 240 of base member 200being located proximal to ramped portion 45 of channel 205 to stop thesliding engagement of handle member 210 with base member 200, along railsegment 230, so as to prevent inadvertent pinching of device 110 inchannel 205, when deploying anchor sleeve 10B via pushing base member200, per arrow P.

FIG. 5A is a perspective view of an exemplary deployment tool 500,according to some alternate embodiments; and FIG. 5B is an explodedperspective view of tool 500. FIGS. 5A-B illustrate tool 500 including abase member 500-B and a handle member 500-H, wherein handle member 500-Hincludes a gripping portion 513 and an elongate tubular member 511,which is laterally offset from gripping portion 513, and which extendsdistally from a junction in an outward protruding ridge 531 of grippingportion 513; an inner surface of tubular member 511 defines a lumen thatextends from an opening at a distal end 51 of member 511 to an openingat a proximal end 52 of member 511 to accommodate insertion of aproximal length of an implanted elongate device, such as device 110(FIG. 1A). FIG. 5B further illustrates base member 500-B including adistal segment 520, through which a channel 505-D extends to receivetubular member 511 of handle portion 500-H in sliding engagementtherewith, and a rail segment 530, about which opposing arms 503 ofgripping portion 513 of handle member 500-H are fitted for slidingengagement therewith. With further reference to FIGS. 5A-B, rail segment530 of base member 500-B, or gripping segment 513 of handle member500-H, may define a longitudinal axis 5 of tool 500, and distal segment520 is shown including a leg member 527 that offsets segment 520 fromaxis 5 by a distance O, so that the laterally offset tubular member 511of handle member 500-H may be received within channel 505-D, whengripping portion 513 is fitted together with rail segment 530. AlthoughFIGS. 5A-B illustrate rail segment 530 including a channel 505-R, whichreceives an inward protruding ridge 56 of gripping segment 513 of handlemember 500-H, for example, to stabilize the engagement between basemember 500-B and handle member 500-H, ridge 56 and channel 505-R mightbe excluded from alternate embodiments.

According to the illustrated embodiment, a distal end portion 55 oftubular member 511 extends distally, from a deployment tip 501 of basemember 500-B, and over a length sufficient to accommodate mounting of ananchor sleeve around an outer surface thereof, for example, sleeve 10Bshown in FIG. 5B. The lateral offset of distal end portion 55 fromgripping portion 513 of handle member 500-H provides clearance betweenan insertion site of an implanted device, for example, device 110, andthose portions of tool 500 that are engaged by an operator betweenfingers and thumb, namely laterally extending tab elements 514 of handlemember 500-H, and proximal terminal end 542 of base member 500-B, topush base member 500-B, per arrows P and D, relative to handle member500-H, and, thereby, deploy the mounted anchor sleeve. Moreover, alength of distal segment 520 may be approximately four inches or more,to accommodate an anchor site that is located deeper within the fasciathan that illustrated in FIG. 1A, or to accommodate an anchor site thatis located below the fascia.

According to some embodiments, handle member 500-H, separate from basemember 500-B, may be included in a kit, such as exemplary kit 275 (FIG.2), with an anchoring sleeve mounted thereon, as shown in FIG. 5B,wherein the kit further includes a converter, for example, a converter50, which is shown in FIG. 5C. FIG. 5C illustrates the exemplaryconverter 50 including a pin member 521, which extends from leg member527, for coupling converter 50 to base member 200 (FIG. 2), for example,via a press fit within the portion of channel 205 that extends alongdistal segment 220, so that base member 200 may converted into aconfiguration, that is similar to base-member 500-B of FIG. 5B, toaccommodate laterally offset tubular member 511 of handle member 500-H,when engaged therewith. FIG. 5C further illustrates converter 50including an auxiliary open channel 515 formed in an auxiliary distalsegment 525 to receive a segment 535 of tubular member 511 (FIG. 5B)during the fitting together of handle member 500-H and the convertedbase member 200, for example, generally according to steps describedabove in conjunction with FIG. 3B. Although not shown, handle member500-H may further include the above-described arrow mark 303 on one onboth of opposing arms 503 of gripping portion 513, similar to handlemembers 210A, 210B, to facilitate alignment and proper orientation ofhandle member 500-H for fitting together with base member 200, in amanner similar to that described above, in conjunction with FIG. 3B.

FIG. 6A is a perspective view of an exemplary deployment tool 600,according to some additional embodiments; and FIG. 6B is an explodedperspective view of tool 600. Tool 600, like tool 500 (FIGS. 5A-B),provides the above-described clearance for the operator during anchorsleeve deployment, since a handle member 600-H thereof includes tubularmember 511 laterally offset from a gripping portion 613 thereof, and abase member 600-B thereof includes distal segment 520, with channel505-D extending therethrough, which is offset, by distance O, from alongitudinal axis 6 of tool 600 by a leg member 627, to accommodate theoffset of tubular member 511. Tool 600 differs from tool 500 in that aproximal end 642 of base member 600-B has a heel element 644 extendingtherefrom, and only one of laterally extending tab elements 514 isincluded in handle member 600-H, for use in conjunction with heelelement 644, wherein the operator may engage the single tab element 514with one or more fingers while abutting a heel of his hand against aproximal surface 604 of heel element 644 to push base member 600-Brelative to handle member 600-H for the deployment of mounted anchorsleeve 10B (shown in FIG. 6B) from distal end portion 55 of tubularmember 511. With further reference to FIGS. 6A-B, tool 600 also differsfrom tool 500 in that an outward protruding ridge 631 of grippingportion 613, which forms the junction with tubular member 511, and legmember 627 of base member 600-B extend in generally the same plane aslaterally extending tab element 514; and opposing arms 603 of grippingportion 613, which extend around rail segment 630 of base member 600-Bto hold handle member 600-H in sliding engagement with rail segment 630of base member 600-B, extend in a direction approximately orthogonal tothe extent of ridge 613.

FIG. 6C is a perspective view of members of an exemplary kit 675,according to some alternate embodiments. FIG. 6C illustrates the membersof kit 675 including handle members 210A, 210B, base member 200,converter 50, and a handle member 600-H2 with mounted anchor sleeve 10B,which is similar to handle-member 600-H, but includes two laterallyextending tab elements 514. According to the illustrated embodiment,converter 50 may be coupled to base member 200, via the press fit of pinmember 521 within channel 205 along distal segment 220, to form aconverted base member, which is similar to base member 600-B of FIG. 6B,but without heel element 644. Although not shown, handle member 600-H2may include the above-described arrow mark 303 on one on both ofopposing arms 603 of gripping portion 613, similar to handle members210A, 210B, to facilitate alignment and proper orientation of handlemember 600-H2 for fitting together with base member 200, in a mannersimilar to that described above, in conjunction with FIG. 3B. Likeopposing arms 203 of handle members 210A, 210B, arms 603 flex outwardand then snap into place around rail segment 230 of base member 200, asrail segment 230 is inserted therebetween.

FIG. 6D is an exploded perspective view of portions of an exemplaryadjustable tool, according to some alternate embodiments. FIG. 6Dillustrates a portion of an adjustable base member 900-B alongside aportion of an adjustable handle member 900-H, which, when fittedtogether with base member 900-B, forms a tool similar to tool 600,described in conjunction with FIGS. 6A-B. Handle member 900-H, likehandle member 600-H, includes gripping portion 613 and tab element 514,but a height H of an outward protruding ridge 931 of handle member900-H, which joins tubular member 511 to gripping portion 613, isadjustable to vary a lateral offset of tubular member 511 from grippingportion 613. Likewise, a leg member 927 of base member 900-B isadjustable to vary distance O of the lateral offset of distal segment520 (FIG. 6A) from rail segment 630 so that the offset corresponds tothe adjusted height H of ridge 931 to accommodate tubular member 511 ina channel 915 (may be open, as shown, or closed like channel 505-D) ofdistal segment 520, when handle member 900-H and base member 900-B arefitted together in sliding engagement. According to FIG. 6D, ridge 931and leg member 927 are each adjustable, for example, per arrows A, bymeans of a telescoping configuration, and each may include detentfeatures 92 to secure ridge 931 to leg member 927 at at least twodifferent offsets.

With reference back to FIG. 6C, handle member 600-H2 may be configuredto include adjustable outward protruding ridge 931, wherein, accordingto an alternate embodiment of kit 675, converter 50 may be configuredwith adjustable leg member 927. Alternately, kit 675 may include aplurality of converters having leg members 527 of different lengths, tocorrespond to the various adjustments of handle member 600-H2 that isconfigured with adjustable ridge 931. Or, for example, with reference toFIG. 6E, another type of adjustable converter 90 may be included in kit675, in lieu of converter 50. FIG. 6E illustrates the exemplaryconverter 90 including a pair of pin members 921 extending from legmember 527, wherein one of pin members 921 is selected to coupleconverter 90 to base member 200 according to selected offset (e.g.height H) of the adjustable handle member.

FIG. 7 is a perspective view of an exemplary deployment tool 700,according to yet further embodiments. FIG. 7 illustrates tool 700including a base member 700-B and a handle member 700-H, which is heldin sliding engagement with base member 700-B, and which includes anelongate tubular member 711 on which anchor sleeve 10B is mounted. Basemember 700-B is similar to base member 200, described above, in thatbase member 700-B includes rail segment 230 and proximal segment 240;and handle member 700-H is similar to handle member 210, describedabove, in that handle member 700-H includes gripping segment 213 whoseopposing arms 203 are fitted around rail segment 230 to hold handlemember 700-H in sliding engagement with base member 700-B. Unlike handlemember 210, a tubular member 711 of handle member 700-H includes acurved segment that extends between gripping segment 213 and a distalend portion of tubular member 711, to orient the distal end portion,about which anchor sleeve 10 is mounted, at an angle with respect to alongitudinal axis 7 of tool 700. Although not shown, it should beunderstood that tubular member 711 includes a lumen to receive aproximal length of an implanted elongate device, for example, likedevice 110 shown in FIG. 1A and in a manner similar to that shown inFIG. 1C.

FIG. 7 further illustrates a distal portion 720 of base member 700-Bhaving a flexible wall 712, which is shown by a cut-away cross-section,to bend around the curved segment of tubular member 711, so that, whenbase member 700-B is pushed relative to handle 700-H, per arrow P, adeployment tip 701 of base member 700-B engages anchor sleeve 10 to movesleeve 10 off tubular member 711, per arrow M, and onto the implanteddevice. According to the illustrated embodiment, tool 700 is useful fordeploying anchor sleeve 10 subcutaneously at an orientation approachingapproximately parallel to a skin surface in which incision 12 (FIG. 1A)is made. Tubular member 711, like tubular member 211, preferablyincludes a lubricious coating that forms an outer surface thereof, tointerface with the mounted anchor sleeve. Flexible wall 712 of basemember distal segment 720 may be formed by a metal coil or braidembedded in a polymer material, according to methods known in the art.

FIG. 8 is a perspective view of an exemplary deployment tool 800,according to another alternate embodiment, wherein a base member 800-Band a handle member 800-H of tool 800 are slidably and pivotably engagedwith one another. FIG. 8 illustrates base member 800-B including alongitudinal segment 820, which is sliding engagement around alongitudinal portion 802 of handle member 800-H, and which is terminatedat a distal end thereof by a deployment tip 801. FIG. 8 furtherillustrates handle segment 800-H including a tubular member 811, whichextends distally from longitudinal portion 802, and an abutment member814, which extends proximally and laterally from longitudinal portion802, and to which a trigger portion 840 of base member 800-B ispivotably coupled at a junction 813. According to the illustratedembodiment, and similar to the above-described embodiments, tubularmember 811 of handle member 800-H has an outer surface sized for themounting of anchor sleeve 10 thereon, as shown, and deployment tip 801of base member 800-B is configured to engage with an end of the mountedanchor sleeve 10 and to move anchor sleeve 10 off from tubular member811 and onto a proximal portion of device 110, which has been insertedthrough a lumen of tubular member 811 to extend out an opening inlongitudinal portion 802 of handle member 800-H. With further referenceto FIG. 8, longitudinal segment 820 of base member 800-B is pushedrelative to handle portion 800-H, per arrow D, to deploy anchor sleeve10, by pulling trigger portion 840 of base member 800-B, per arrow P,proximally toward abutment member 814 of handle member 800-H. Dashedlines in FIG. 8 depict that part of trigger portion 840 that joins withlongitudinal segment 820 within a sidewall of handle portion 800-H.After deploying anchor sleeve 10, when trigger portion 840 is released,a bias of a spring member 823, which is shown coupled between triggerportion 840 and abutment member 814, returns base member 800-B to a‘pre-push’ position with respect to handle member 800-H.

In the foregoing detailed description, specific exemplary embodimentshave been described. However, it may be appreciated that variousmodifications and changes can be made without departing from the scopeof the disclosure as set forth in the appended claims. Furthermore,deployment tools and kits for forming deployment tools, which includevarious combinations of features described above in conjunction with thespecific embodiments, are within the scope of the present invention, forexample, according to the following 13 statements that disclose featuresor combinations of features in exemplary embodiments:

1. In some exemplary embodiments, a tool for deploying an anchor sleeveonto an implantable elongate medical device, the tool comprising: ahandle member including a gripping portion, an elongate tubular memberextending distally from the gripping portion, and a junction between thetubular member and the gripping portion, the gripping portion defining alongitudinal axis of the tool, the tubular member having an outersurface sized for mounting the anchor sleeve thereon, and an innersurface defining a lumen extending longitudinally from a proximalopening, in proximity to the junction, to a distal opening, and thelumen being sized to receive a proximal length of the implantable devicetherein; and an elongate base member including a deployment tip and anelongate channel, the channel extending proximally from an opening atthe deployment tip; wherein the channel of the base member receives thetubular member of the handle member in sliding engagement, when thegripping portion of the handle member is fitted around the base member;and the deployment tip of the base member is configured to engage withan end of the anchor sleeve, when the anchor sleeve is mounted on thetubular member of the handle member, and when the gripping portion ofthe handle member is fitted around the base member.

2. In some exemplary embodiments, the junction between the tubularmember and the gripping portion of the handle member comprises: a borehole, formed through an inner ridge of the gripping portion, the innerridge extending between opposing arms of the gripping portion and beingconfigured to fit in sliding engagement within the channel of the basemember, when the opposing arms are fitted around the base member; aproximal length of the tubular member press fit within the bore hole;and a flared end of the tubular member, the flared end abutting asurface of the inner ridge of the gripping portion that extends aroundan opening of the bore hole.

3. Some exemplary embodiments include the tool of statement 1 or 2,wherein the outer surface of the tubular member of the handle membercomprises a lubricious coating.

4. Some exemplary embodiments include the tool of any of statements 1-3,

wherein the base member further includes holes formed through an exposedside of the base member, the exposed side extending between ends ofopposing arms of the gripping portion of the handle member, when thearms are fitted around the base member.

5. Some exemplary embodiments include the tool of any of statements 1-4,wherein: the base member further comprises a rail segment and a proximalsegment, the rail segment extending proximally from the deployment tip,and opposing arms of the gripping portion of the handle member extendingaround the rail segment, when the gripping portion is fitted around thebase member; the channel of the base member extends through the railsegment and into the proximal segment; and the rail segment of the basemember includes recessed sidewalls that extend distally from shouldersof the proximal segment, the shoulders of the proximal segment stoppingthe sliding engagement of the handle member along the rail segment.

6. Some exemplary embodiments include the tool of any of statements 1-5,wherein: the tubular member of the handle member includes a curvedsegment such that a distal end portion of the tubular member extends atan angle with respect to the longitudinal axis of the tool, when theopposing arms of the handle member are fitted around the base member;and the base member further comprises a distal segment, the distalsegment being terminated by the deployment tip and being flexible tobend around the curved segment of the tubular member of the handlemember, when the handle member is fitted around the base member.

7. Some exemplary embodiments include the tool of any of statements 1-4,wherein: the deployment tip of the base member is laterally offset fromthe longitudinal axis of the tool; an entirety of the tubular member ofthe handle member is laterally offset from the gripping portion of thehandle member; and when the gripping portion of the handle member isfitted around base member, the tubular member of the handle memberextends approximately parallel to the longitudinal axis of the tool.

8. Some exemplary embodiments include the tool of statement 7, whereinthe lateral offsets of the tubular member of the handle member and ofthe deployment tip of the base member are adjustable.

9. Some exemplary embodiments include a tool kit for forming a toolaccording to any of statements 1-5, the tool kit comprising: a pluralityof handle members, each handle member of the plurality according to anyof statements 1-5; a plurality of anchor sleeves, each anchor sleeve ofthe plurality being mounted on the tubular member of a correspondinghandle member of the plurality of handle members; and an elongate basemember according to any of statements 1-5.

10. In some exemplary embodiments, the tool kit of statement 9, whereinthe tool kit further forms a tool according to statement 8, the tool kitfurther comprising: another handle member according to statement 7; ananchor sleeve being mounted on the tubular member of the other handlemember; and a converter configured for attachment to the distal segmentof the base member, the converter including a leg member, an auxiliarydistal segment, which extends from the leg member, and an auxiliarychannel extending through the auxiliary distal segment, the auxiliarydistal segment being laterally offset, by the leg member, from the railsegment of the base member, when the converter is attached to the distalsegment of the base member; and wherein, when the converter is attachedto the base member and the other handle member is held in slidingengagement with the base member, the auxiliary channel of the auxiliarydistal segment of the converter is located to receive the tubular memberof the other handle member.

11. In some exemplary embodiments, the tool kit of statement 10, whereinthe lateral offsets of the tubular member of the other handle member andthe auxiliary distal segment of the converter are adjustable.

12. In some exemplary embodiments, the tool kit of statement 10,wherein: the lateral offset of the tubular member of the other handlemember is adjustable; and the converter is one of a plurality ofconverters included in the kit, each converter having a differentlateral offset of the corresponding auxiliary distal segment, toaccommodate the adjustable lateral offset of the tubular member of theother handle member.

13. Some exemplary embodiments include the tool kit of any of statements9-12, wherein the base member further comprises a marked portion toguide alignment of the gripping portion of any one of the plurality ofhandle members when fitting opposing arms of the gripping portion aroundthe base member.

The invention claimed is:
 1. A tool for deploying an anchor sleeve ontoan implantable elongate medical device, the tool comprising: a handlemember including a gripping portion and an elongate tubular memberextending distally from the gripping portion, the gripping portionincluding opposing arms, and the tubular member including a distal endportion being laterally offset from the gripping portion, an innersurface defining a longitudinally extending lumen, the lumen being sizedto receive a proximal length of the implantable device therein, and anouter surface sized for mounting the anchor sleeve thereon; and anelongate base member including a deployment tip, a distal segment, arail segment, and an elongate channel, the distal segment beingterminated by the deployment tip and extending between the deploymenttip and the rail segment, the rail segment defining a longitudinal axisof the tool and extending proximally from the distal segment, thechannel extending proximally from an opening at the deployment tip andthrough the distal segment, and the deployment tip being laterallyoffset from the longitudinal axis of the tool; wherein the channel ofthe base member is sized to receive the tubular member of the handlemember in sliding engagement, when the opposing arms of the grippingportion of the handle member are fitted around the rail segment of thebase member, the opposing arms being configured to hold the handlemember in sliding engagement with the base member, along the railsegment thereof; and the deployment tip of the base member is configuredto engage with an end of the anchor sleeve, when the anchor sleeve ismounted on the distal end portion of the tubular member, and when theopposing arms of the handle member hold the handle member in slidingengagement with the base member.
 2. The tool of claim 1, wherein anentirety of the tubular member of the handle member is laterally offsetfrom the gripping portion thereof; and, when the handle member is heldin sliding engagement with the base member, the tubular member of thehandle member extends approximately parallel to the longitudinal axis ofthe tool.
 3. The tool of claim 2, wherein the lateral offsets of thetubular member of the handle member and of the deployment tip of thebase member are adjustable.
 4. The tool of claim 1, wherein: the tubularmember of the handle member includes a curved segment extending betweenthe gripping portion thereof and the distal end portion of the tubularmember; and the distal segment of the base member is flexible to bendaround the curved segment of the tubular member, when the handle memberis held in sliding engagement with the base member.